This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Lee, W. Anthony, M.D. FACS
Sponsor:
Collaborator:
William Cook Australia
Information provided by (Responsible Party):
Lee, W. Anthony, M.D. FACS
ClinicalTrials.gov Identifier:
NCT01524211
First received: January 30, 2012
Last updated: April 2, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.

Condition Intervention Phase
Thoracoabdominal Aortic Aneurysm Device: Zenith® t-Branch Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Lee, W. Anthony, M.D. FACS:

Primary Outcome Measures:
  • Early Mortality [ Time Frame: 30 days post implant of the branch endografts ]
    The primary aim of this study is to determine the rate of early mortality after branch endograft treatment.


Secondary Outcome Measures:
  • Rates of Neurologic Complications/Late Branch Vessel Patency [ Time Frame: Day 0-Day 30 (Early) Day 31-1825 (Late) ]
    The secondary aims of this study are to determine the rates of neurologic complications and late branch vessel patency after branch endograft treatment, and the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms


Estimated Enrollment: 125
Study Start Date: January 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Treatment Arm
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
Device: Zenith® t-Branch
The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.

Detailed Description:
Study Update as of 4/2/2017;77 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

The patient must have one of the following:

  1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
  2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
  3. Penetrating ulcers: ≥20mm in depth or
  4. Chronic type B aortic dissections: ≥50mm total aortic diameter or
  5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Exclusion Criteria

General Criteria

  1. Life-expectancy less than 12 months
  2. Refusal to receive blood products
  3. Age <18 years
  4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  5. Unwilling to comply with the follow-up schedule
  6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized

Medical Criteria

  1. Uncontrolled systemic infection
  2. Untreatable malignancy
  3. Uncontrollable anaphylaxis to iodinated contrast
  4. Known allergy(ies) to device materials

Anatomic Criteria

  1. Any pathology of mycotic origin
  2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
  3. Inability to insert the Zenith® t-Branch device through iliofemoral approach
  4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
  5. Proximal landing zone length <25mm to allow secure fixation and seal
  6. Proximal landing zone diameter of <24mm or >42mm
  7. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
  8. Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524211

Contacts
Contact: Lisamarie Kernicky, RN;BSN;CCRC 561-955-5239 lkernicky@brrh.com

Locations
United States, Florida
Boca Raton Regional Hospital (BRRH) Recruiting
Boca Raton, Florida, United States, 33486
Contact: Lisamarie Kernicky, RN;BSN;CCRC    561-955-5239    lkernicky@brrh.com   
Sponsors and Collaborators
Lee, W. Anthony, M.D. FACS
William Cook Australia
Investigators
Principal Investigator: W. Anthony Lee, MD Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
  More Information

Responsible Party: Lee, W. Anthony, M.D. FACS
ClinicalTrials.gov Identifier: NCT01524211     History of Changes
Other Study ID Numbers: IDE G110081
Study First Received: January 30, 2012
Last Updated: April 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Lee, W. Anthony, M.D. FACS:
Aortic Aneurysms

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on June 27, 2017